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Session 2: Impact of The Clinical Trial Regulation On Pharmacovigilance
Session Chair(s)
Willemijn van der Spuij, MSc
Executive Director, WorldWide Patient Safety International, Europe
Switzerland
This session will explore the current understanding of the impact of the Clinical Trial Regulation on safety activities in clinical trials. Various aspects of the new Regulation will be explored and differences between the present and new requirements for managing clinical trials in the face of forthcoming changes will be looked at. This includes topics such as the CTA Portal and potential safety information (Serious Breach, Non-Clinical SUSARs and/or increase in non-serious AR), understanding the impact of the transition period on safety, the DSUR Portal, RSI and low risk trials.
Speaker(s)
Safety in Clinical Trials under the Clinical Trial Regulation: Major Challenges
Elena Prokofyeva, MD, PhD, MPH
Federal Agency for Medicines and Health Products (FAMHP), Belgium
Head of Drug Safety Unit, Department of Research & Development, DG PRE
Safety in Clinical Trials under the Clinical Trial Regulation: Major Challenges
Barbara Reinhardt
Merck Healthcare KGaA, Germany
Associate Director | Global Patient Safety | Safety Science
Clinical Trial Portal Implementation: Implications for DSURs
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department